Special Warning : אזהרת שימוש

Warnings

RISK OF MEDICATION ERRORS
Take care to avoid dosing errors due to confusion between milligram (mg) and milliliter (mL), which could result in accidental overdose and death (see section 4.2).

It is recommended to use a suitable analgesic oral treatment as soon as this administration route is possible.

In order to avoid the risk of overdose, check that other medicines (including prescription and nonprescription) administered do not contain either paracetamol or propacetamol.

Doses higher than the recommended entails risk for very serious liver damage. Clinical symptoms and signs of liver damage (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis) are usually first seen after two days of drug administration with a peak seen usually after 4 - 6 days. Treatment with antidote should be given as soon as possible (See section 4.9).
Paracetamol can cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity 
This medicinal product contains less than 1 mmol sodium (23mg) per 100ml of Perfalgan, i.e.
essentially "sodium free".

As for all solutions for infusion presented in glass vials, a close monitoring is needed notably at the end of the infusion (see section 4.2).

Precautions for use

Paracetamol should be used with caution in cases of:
   Hepatocellular insufficiency
   Severe renal insufficiency (see sections 4.2 and 5.2)
   Glucose-6-phosphate dehydrogenase deficiency (may lead to haemolytic anemia)    Chronic alcoholism excessive alcohol intake (3 or more alcoholic drinks every day)    anorexia, bulimia or cachexia
   Chronic malnutrition (low reserves of hepatic gluthatione)
   Dehydration, hypovolemia

Effects on Driving

4.7 Effects on ability to drive and use machines

Not relevant.